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Recruiting

NCT Number: NCT07437911

A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Supplement on Nutrient Gaps and Gut Health Among Individuals Utilizing GLP-1 RAs

This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.

Recruiting

Interested in participating?

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be male or female
  • Be aged 18-59.
  • Has a BMI between 20-31.9.
  • Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide (Ozempic®, Wegovy®, Rybelsus®), Liraglutide (Saxenda®, Victoza®), Dulaglutide (Trulicity®), Exenatide (Byetta®, Bydureon®), Lixisenatide (Adlyxin®)
  • Anyone willing to follow the study protocol, including immediately prior to the all blood tests, duplicating their diet for 72 hours (3 days), refraining from caffeine and exercise for 24 hours, and fasting for 10 hours.
  • Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
  • Anyone willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of this trial.
  • Anyone who is generally healthy - does not live with any diagnosed uncontrolled chronic disease.
  • Has access to a consistent weighing scale for the duration of the study.
  • Resides in the United States.

Exclusion criteria

  • Anyone with a diagnosis of Type I or Type II diabetes.
  • Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.
  • Anyone who has taken any multivitamin/multimineral supplements within the past 3 months.
  • Anyone who has taken a probiotic supplement within the past month.
  • Anyone who has regularly consumed (5 days/week or more) products that target healthy aging, anti-aging, longevity, gut health, energy, or ingestive behaviour (such as cravings), including resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, prebiotic fiber, green tea, niacin (vitamin B3) within the past 2 months.
  • Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days.
  • Anyone who has a known history of severe digestive disorders or metabolic conditions that impact nutrient absorption or metabolism, including acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, a history of colon resection, gastroparesis, Inborn errors of metabolism (such as PKU), or gastrointestinal tract surgeries.
  • Anyone with any known allergies or hypersensitivities to any supplement product ingredients.
  • Anyone with any chronic health conditions that could impact participation in this study, such as asthma, gout, fibromyalgia, chronic inflammatory conditions (such as Crohn's, Lupus, HIV/AIDS), thyroid conditions, cancer (within the past 5 years), mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
  • Anyone currently pregnant, trying to conceive, or breastfeeding.
  • Anyone who has undergone a change in hormone therapy (including oral contraceptives) within the past 4 weeks, or is unwilling to maintain their current hormone therapy/oral contraceptive use throughout the course of the study.
  • Anyone who consumes more than 2 standard alcoholic drinks per day or more than 10 drinks per week, or has within the past 6 months.
  • Anyone who is currently a smoker or has been a smoker within the past month.
  • Anyone who follows a specific exclusion diet, including vegan, vegetarian, carnivore, paleo, atkins, or ketogenic.

Treatment and study plan

AG1 - Nutritional Supplement

Dietary Supplement

AG1 - Nutritional Supplement

Placebo

Dietary Supplement

Maltodextrin Placebo

Primary outcomes

  1. Nutrient Gaps

    Time frame: 90 days

    Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool

Secondary outcomes

  1. Nutrient Status Markers

    Time frame: 90 days

    Circulating concentrations of nutrient status (homocysteine, folate, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Zinc)

  2. Gut Microbiome

    Time frame: 90 days

    Examine changes in the gut microbiome via fecal metagenomics

Other outcomes

  1. GI Symptoms

    Time frame: 90 days

    The Gastrointestinal Symptom Rating Scale will be provided to assess the effect of the intervention on GI symptoms. Scores range from 1 to 7 with a higher score indicating a higher level of discomfort

  2. Digestive Quality of Life

    Time frame: 90 days

    A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life

  3. Functional Impairment

    Time frame: 90 days

    The Sheehan Disability Scale will be utilized to assess functional impairment.

  4. Ingestive Behavior

    Time frame: 90 days

    Food cravings will be measured using the General Food Cravings Questionnaire.

  5. Energy

    Time frame: 90 days

    The Fatigue Assessment Scale will be utilized to assess the impact of the intervention on symptoms of fatigue.

  6. Serum concentrations of sodium

    Time frame: 90 days

    Measured using a Comprehensive Metabolic Panel

  7. Serum concentrations of Potassium

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  8. Serum concentrations of carbon dioxide

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  9. Serum concentrations of chloride

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  10. Serum concentrations of albumin

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  11. Serum concentrations of total protein

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  12. Serum concentrations of glucose

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  13. Serum concentrations of calcium

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  14. Serum concentrations of ALT

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  15. Serum concentrations of AST

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  16. Serum concentrations of bilirubin

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

  17. Serum concentrations of Blood Urea Nitrogen

    Time frame: 90 days

    Measured in a Comprehensive Metabolic Panel

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen O'Gorman

CONTACT

[email protected]

(805) 292-0714

Jodi Nicolli

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Athletic Greens International

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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